Ignite Creation Date:
2024-07-17 @ 11:56 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06471517
Status:
RECRUITING
Last Update Posted:
2024-06-24
First Post:
2024-06-13
Brief Title:
Neuroprosthetic Device for Improving Issues Caused by Diabetic Neuropathy With Specifically Designed Neural Stimulation
Sponsor:
Institute Mihajlo Pupin
Organization:
Institute Mihajlo Pupin
Study Overview
Official Title:
Neuroprosthetic Device for Improving Issues Caused by Diabetic Neuropathy With Specifically Designed Neural Stimulation
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DiabeticStim
Brief Summary:
Neuropathy refers to a condition that results from damage to the peripheral nervesThe most common cause of it is diabetes mellitus metabolic disorder that affects more than 422 million individuals worldwide putting a huge strain on the healthcare system and up to 50 of these individuals will develop neuropathy Peripheral neuropathy is characterized by sensory nerve abnormalities such as an impaired sense of touch Sensory loss in feet can lead to functional deficits during gait low balance and increased risk of falls and is considered the strongest risk factor for diabetic foot ulceration Moreover these patients usually also suffer from neuropathic pain which is believed to be associated with aberrant sensory input
With this in mind the study aims to understand the effects of restoring sensation lost to neuropathy using transcutaneous electrical stimulation Additionally the investigators aim to understand if electrical stimulation of the damaged nerves can reduce health consequences such as chronic pain
To achieve this the investigators have developed a wearable sensory restoration system that can restore lost sensation with non-invasive precisely controlled electrical stimulation through electrodes integrated into the sock garment A system is composed of a system controller that communicates via Bluetooth with force-sensitive insoles placed in the shoes and neurostimulators directly connected to electrode array socks Based on the insole recordings the stimulation parameters are defined in real-time making it a closed-loop system for restoring somatotopic sensory feedback
With this in mind the study aims to understand the effects of restoring sensation lost to neuropathy using transcutaneous electrical stimulation Additionally the investigators aim to understand if electrical stimulation of the damaged nerves can reduce health consequences such as chronic pain
To achieve this the investigators have developed a wearable sensory restoration system that can restore lost sensation with non-invasive precisely controlled electrical stimulation through electrodes integrated into the sock garment A system is composed of a system controller that communicates via Bluetooth with force-sensitive insoles placed in the shoes and neurostimulators directly connected to electrode array socks Based on the insole recordings the stimulation parameters are defined in real-time making it a closed-loop system for restoring somatotopic sensory feedback
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None